Janagliflozin Treat T2DM Monotherapy

NCT ID: NCT03811548

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-23
• Study Completion Date: 2020-12-31

Brief Summary

The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics.

Detailed Description

A multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 Weeks Extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg. During the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally once daily.

Conditions

Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Janagliflozin 25mg

Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)

Group Type: EXPERIMENTAL

Janagliflozin 25mg

Intervention Type: DRUG

Tablets, Oral, 25 mg, Tablets, Oral, 50 mg

Janagliflozin 50mg

Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)

Group Type: EXPERIMENTAL

Janagliflozin 50mg

Intervention Type: DRUG

Tablets, Oral, 25 mg, Once daily, 52 weeks

Placebo/Janagliflozin

In the core period, each patient will receive placebo once daily for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin once daily until Week 52.

Group Type: EXPERIMENTAL

Placebo/Janagliflozin

Intervention Type: DRUG

Tablets, Oral, 25 mg, Once daily, 52 weeks

Interventions

Janagliflozin 25mg

Tablets, Oral, 25 mg, Tablets, Oral, 50 mg

Intervention Type: DRUG

Janagliflozin 50mg

Tablets, Oral, 25 mg, Once daily, 52 weeks

Intervention Type: DRUG

Placebo/Janagliflozin

Tablets, Oral, 25 mg, Once daily, 52 weeks

Intervention Type: DRUG

Other Intervention Names

Placebo 50mg; Placebo 25mg

Eligibility Criteria

Inclusion Criteria

• All patients must have a diagnosis of T2DM (meet the diagnostic criteria for diabetes issued by the World Health Organization in 1999)
• Patients must have a hemoglobin A1c (HbA1c) level ≥7.5% and ≤11% at screening, and ≥7.0% and ≤10.5% at baseline.
• Drug -naïve (never received anti-diabetic medication or did not receive anti-diabetic medication within 8 weeks before screening).
• Body Mass Index: 18.0~35.0 kg/m2 (both inclusive)

Exclusion Criteria

• History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
• More than 10% change in body weight within the 3 months before screening
• Any laboratory test indicators meet the following standards:

• fasting plasma glucose ≥ 15 mmol/L
• aspartate aminotransferase, alanine aminotransferase levels > 3 times the upper limit of normal (ULN); total bilirubin > 1.5 times ULN
• hemoglobin < 100 g/L
• eGFR < 60 mL/min/1.73m2
• fasting triglycerides > 5.64 mmol/L (500 mg/dL)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sihuan Pharmaceutical Holdings Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Linong Ji

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Leili Gao, Doctor

Role: CONTACT

plum_jj@sina.com

00861088325578 ext. 00861088324516

Linong Ji, Doctor

Role: CONTACT

jiln@bjmu.edu.cn

00861088325578 ext. 00861088324516

Facility Contacts

Linong Ji

Role: primary

plum_jj@sina.com

00861088325578 ext. 00861088325578

Other Identifiers

5695-DIA-3001

Identifier Type: -

Identifier Source: org_study_id